MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRANSEND; WIRE, GUIDE, CATHETER

Model Number	81735
Medical Device Problem Codes	Failure to Advance (2524); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that wire detachment occurred requiring additional intervention.Vascular access was obtained via the ulnar cutaneous vein of the upper arm.The totally occluded target lesion was located in the moderately calcified radial cutaneous vein.A 135cm gw transend periph guidewire was selected for use in a shunt percutaneous transluminal angioplasty procedure.During the procedure, the guidewire was unable to cross the lesion and when attempted to remove, a difficulty was encountered.The wire was detached at around 5cm from the tip and the separated fragment was retrieved with a snare.The procedure was then completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a gw transend periph.The device was returned for the analysis, and it is possible to see that the guidewire detached at the distal tip section, and coating was peeled.A part of the original box was returned, and it was observed that the pouch information matches with the complaint information.
Event or Problem Description
It was reported that wire detachment occurred requiring additional intervention.Vascular access was obtained via the ulnar cutaneous vein of the upper arm.The totally occluded target lesion was located in the moderately calcified radial cutaneous vein.A 135cm gw transend periph guidewire was selected for use in a shunt percutaneous transluminal angioplasty procedure.During the procedure, the guidewire was unable to cross the lesion and when attempted to remove, a difficulty was encountered.The wire was detached at around 5cm from the tip and the separated fragment was retrieved with a snare.The procedure was then completed with a different device.No patient complications were reported.

• Brand Name: TRANSEND
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18707386
• Report Number: 2124215-2024-08689
• Device Sequence Number: 8508489
• Product Code: DQX
• UDI-Device Identifier: 08714729326274
• UDI-Public: 08714729326274
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K941710
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/29/2025
• Device Model Number: 81735
• Device Catalogue Number: 81735
• Device Lot Number: 0031929327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown